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Background Following the success of the CAVD-VIMC ELISpot comparison study, the CAVD-VIMC ELISpot Assay Transfer study was designed to evaluate the transfer of the ELISpot assay SOP from IAVI CL to NVITAL using the same set of 150 samples. Assay results for the parent SOP (IAVI) from the comparison study will be used to compare to those for the transferred SOP (NVITAL). The co-primary objectives are to ensure that the response rates are equivalent and the positivity calls are concordant. Concordance of response magnitudes among the dynamic range of positive responders is evaluated in the secondary objectives.

P16-19. Statistical design and analysis of the CAVD-VIMC Elispot transfer study 001